Herpes ZosterNCT05348382
The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster
A study testing Intradermal acupuncture in people with Herpes Zoster, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 2 sites in China.
Trial summary
Herpes zoster (HZ), also commonly known as shingles, is characterized by a bandlike rash in the dermatome that corresponds to the affected nerve. Pain is prevalent in HZ patients, which may be provoked by light touch. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Intradermal acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- 4 Jul 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have confirmed diagnosis of herpes zoster;
- Herpes zoster is in the acute stage and participants have not yet received antiviral treatment or analgesic treatment;
- 18≤Age≤80 years, regardless of gender;
- Significant pain with a visual analog scale (VAS) score ≥ 4;
- Absence of other diseases causing skin temperature change;
- Participants can understand the study procedure and agree to sign the informed consent form.
Who cannot join
- Participants have some specific types of herpes zoster, such as disseminated herpes zoster; or herpes zoster is located on regions that are not suitable for intradermal acupuncture, such as the head, face, or perineum.
- Pregnant or lactating subjects;
- Participants have scar constitution or have severe cardiovascular, hepatic, renal, and hematopoietic system diseases that result in bleeding tendency, thereby making them unsuitable for intradermal acupuncture;
- Participants with severe cognitive impairment who are unable to fully understand the trial protocol;
- Participants are taking part in other trials.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Hantong Hu, MD, 18667103032 ext. 86, thevervecn@163.com
Dexiong Han, MD, 15017541803 ext. 86, han_0213@163.com
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Hantong Hu, 18667103032 ext. 86, 413351308@qq.com
About this study
Official title: The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial
Herpes zoster (HZ), also commonly known as shingles, is characterized by a bandlike rash in the dermatome that corresponds to the affected nerve. Pain is prevalent in HZ patients, which may be provoked by light touch. Postherpetic neuralgia (PHN) is one of the most common complications of HZ and it is generally intractable to treat.
At present, common treatment methods for HZ include anti-inflammatory, antiviral, analgesic, and neuroleptic regimens. Nevertheless, the application of these therapies can sometimes be limited by side effects. In this scenario, it is urgent to seek alternative non-pharmacological therapies for treating HZ.
Intradermal acupuncture (IDA) is a common type of acupuncture. By retaining the needles for a much longer duration than other common modalities of acupuncture, IDA can prolong the sustained effect of acupuncture. In addition, characterized by mild pain during the insertion of intradermal needles, IDA is more suitable for patients who fear conventional acupuncture and it is also easy to operate by practitioners. Therefore, concerning the treatment of pain conditions, such as acute HZ, it may have certain advantages over conventional acupuncture. Thus, The aim of this trial is to evaluate the efficacy and safety of IDA for acute HZ.
Read the detailed description
This randomized controlled trial will enroll 72 eligible patients with acute herpes zoster. Participants who are confirmed eligibility will be randomly allocated to either the IDA group or the sham IDA group in a 1:1 ratio. The duration of the trial will include two study phases, including a 1-month intervention phase and a 3-month follow-up phase.
- Conditions
- Herpes Zoster
- Being tested
- Intradermal acupuncture, Sham intradermal acupuncture
- Keywords
- herpes zoster, intradermal acupuncture, infrared thermography, clinical trial
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal acupunctureProcedure or surgery
In addition to basis standard pharmacological treatments, intradermal needles will be inserted in each selected acupoint and retained in place for 48 hours. Points around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. The operator will tear off the adhesive tape of intradermal needles and stick them on the selected acupoints, and then apply pressure on intradermal needles over the selected acupoints perpendicularly according to the patient's tolerance. In addition, patients will be instructed to press the intradermal needles 4 times per 24 hours throughout the needle retention period, with the aim to increase stimulation for treatment enhancement, each time lasting around 30 seconds.
Sham intradermal acupunctureProcedure or surgery
In addition to basis standard pharmacological treatments, sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. Additionally, participants in the sham intradermal acupuncture group will be treated in another room to avoid direct communications with subjects in the IDA group.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal acupuncture group | Experimental | Points around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. Receives: Procedure: Intradermal acupuncture |
| Sham intradermal acupuncture group | Sham comparator | Sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. Receives: Procedure: Sham intradermal acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
The pain intensity is assessed using the 10-point Visual Analog Scale (VAS)
Measured: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
Stopping time of herpes zoster
the number of days required for herpes zoster to stop increasing
Measured: through study completion (up to 4 months)
Crusting time of herpes zoster
the number of days required for herpes zoster crusting
Measured: through study completion (up to 4 months)
Removal time of herpes zoster scabs
the number of days required for all herpes zoster scabs to be completely shed
Measured: through study completion (up to 4 months)
Change in the temperature of regions of interest (ROIs)
The temperature of ROIs will be assessed by infrared thermography.
Measured: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
Incidence rate of postherpetic neuralgia (PHN)
The incidence rate of PHN will be assessed by calculating the percentage of patients who suffer from PHN
Measured: at 3-month follow-up
Secondary outcomes (2)
Change in quality of life
The 36-item Short Form Health Survey (SF-36) will be utilized to assess the quality of life.
Measured: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
Adverse events
Incidence of adverse events
Measured: through study completion (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start4 Jul 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hantong Hu, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Hantong Hu, MD, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348382
- Sponsor's protocol ID
- 2022ZB184
- Status last verified
- Jul 2022
- First submitted
- 17 Apr 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.
PubMed 34095161Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.
PubMed 19674449Hu H, Cheng Y, Wu L, Han D, Ma R. Investigating the Therapeutic Effect of Intradermal Acupuncture for Acute Herpes Zoster and Assessing the Feasibility of Infrared Thermography for Early Prediction of Postherpetic Neuralgia: Study Protocol for a Randomized, Sham-Controlled, Clinical Trial. J Pain Res. 2023 Apr 26;16:1401-1413. doi: 10.2147/JPR.S406841. eCollection 2023.
PubMed 37131531
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05348382
- Acronym / sponsor ID
- 2022ZB184
- Conditions
- Herpes Zoster
- Keywords
- herpes zoster, intradermal acupuncture, infrared thermography, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Herpes zoster (HZ), also commonly known as shingles, is characterized by a bandlike rash in the dermatome that corresponds to the affected nerve. Pain is prevalent in HZ patients, which may be provoked by light touch. Postherpetic neuralgia (PHN) is one of the most common complications of HZ and it is generally intractable to treat.
At present, common treatment methods for HZ include anti-inflammatory, antiviral, analgesic, and neuroleptic regimens. Nevertheless, the application of these therapies can sometimes be limited by side effects. In this scenario, it is urgent to seek alternative non-pharmacological therapies for treating HZ.
Intradermal acupuncture (IDA) is a common type of acupuncture. By retaining the needles for a much longer duration than other common modalities of acupuncture, IDA can prolong the sustained effect of acupuncture. In addition, characterized by mild pain during the insertion of intradermal needles, IDA is more suitable for patients who fear conventional acupuncture and it is also easy to operate by practitioners. Therefore, concerning the treatment of pain conditions, such as acute HZ, it may have certain advantages over conventional acupuncture. Thus, The aim of this trial is to evaluate the efficacy and safety of IDA for acute HZ.
Detailed description
This randomized controlled trial will enroll 72 eligible patients with acute herpes zoster. Participants who are confirmed eligibility will be randomly allocated to either the IDA group or the sham IDA group in a 1:1 ratio. The duration of the trial will include two study phases, including a 1-month intervention phase and a 3-month follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal acupuncture group | Experimental | Procedure: Intradermal acupuncturePoints around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. |
| Sham intradermal acupuncture group | Sham comparator | Procedure: Sham intradermal acupunctureSham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants have confirmed diagnosis of herpes zoster;
- Herpes zoster is in the acute stage and participants have not yet received antiviral treatment or analgesic treatment;
- 18≤Age≤80 years, regardless of gender;
- Significant pain with a visual analog scale (VAS) score ≥ 4;
- Absence of other diseases causing skin temperature change;
Key exclusion criteria (5 listed)
- Participants have some specific types of herpes zoster, such as disseminated herpes zoster; or herpes zoster is located on regions that are not suitable for intradermal acupuncture, such as the head, face, or perineum.
- Pregnant or lactating subjects;
- Participants have scar constitution or have severe cardiovascular, hepatic, renal, and hematopoietic system diseases that result in bleeding tendency, thereby making them unsuitable for intradermal acupuncture;
- Participants with severe cognitive impairment who are unable to fully understand the trial protocol;
- Participants are taking part in other trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal acupunctureIn addition to basis standard pharmacological treatments, intradermal needles will be inserted in each selected acupoint and retained in place for 48 hours. Points around the herpes zoster sites (about 1 cm peripherally) are selected for intradermal acupuncture (IDA) encircled needling. Meanwhile, intradermal acupuncture is also performed in Ashi acupoints in the distribution area of herpes zoster. The operator will tear off the adhesive tape of intradermal needles and stick them on the selected acupoints, and then apply pressure on intradermal needles over the selected acupoints perpendicularly according to the patient's tolerance. In addition, patients will be instructed to press the intradermal needles 4 times per 24 hours throughout the needle retention period, with the aim to increase stimulation for treatment enhancement, each time lasting around 30 seconds. | Procedure or surgery | Intradermal acupuncture group |
| Sham intradermal acupunctureIn addition to basis standard pharmacological treatments, sham intradermal acupuncture will be implemented in the same acupoints as the intradermal acupuncture group using pseudo-intradermal needling. Additionally, participants in the sham intradermal acupuncture group will be treated in another room to avoid direct communications with subjects in the IDA group. | Procedure or surgery | Sham intradermal acupuncture group |
Primary outcome
Change in pain intensity
Time frame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
The pain intensity is assessed using the 10-point Visual Analog Scale (VAS)
Stopping time of herpes zoster
Time frame: through study completion (up to 4 months)
the number of days required for herpes zoster to stop increasing
Crusting time of herpes zoster
Time frame: through study completion (up to 4 months)
the number of days required for herpes zoster crusting
Removal time of herpes zoster scabs
Time frame: through study completion (up to 4 months)
the number of days required for all herpes zoster scabs to be completely shed
Change in the temperature of regions of interest (ROIs)
Time frame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
The temperature of ROIs will be assessed by infrared thermography.
Incidence rate of postherpetic neuralgia (PHN)
Time frame: at 3-month follow-up
The incidence rate of PHN will be assessed by calculating the percentage of patients who suffer from PHN
2 secondary outcomes
Change in quality of life
Time frame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up
Adverse events
Time frame: through study completion (up to 4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 34095161Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.
- Background: PubMed 19674449Fleckenstein J, Kramer S, Hoffrogge P, Thoma S, Lang PM, Lehmeyer L, Schober GM, Pfab F, Ring J, Weisenseel P, Schotten KJ, Mansmann U, Irnich D. Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial. BMC Complement Altern Med. 2009 Aug 12;9:31. doi: 10.1186/1472-6882-9-31.
- Derived from this study: PubMed 37131531Hu H, Cheng Y, Wu L, Han D, Ma R. Investigating the Therapeutic Effect of Intradermal Acupuncture for Acute Herpes Zoster and Assessing the Feasibility of Infrared Thermography for Early Prediction of Postherpetic Neuralgia: Study Protocol for a Randomized, Sham-Controlled, Clinical Trial. J Pain Res. 2023 Apr 26;16:1401-1413. doi: 10.2147/JPR.S406841. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hantong Hu, MD principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal acupuncture in people with Herpes Zoster, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Wu, MD (18958077903 ext. 86, 413351308@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: at baseline (pre-treatment), at 1 month after intervention, at 3-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348382, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.